Tongue Depressor-related Tongue Swelling

Children, Only Clinical Trial

Official title:

Tongue Depressor-related Tongue Swelling in Adenoidectomy Surgeries in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04256590
• Other study ID #: 2018/18
• Status: Completed
• Start date: September 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: February 2020
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.

Description:

The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue swelling through USG examination and to educate clinicians about the association between subacute tongue swelling and tongue depressor in pediatric patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

Inclusion Criteria:

• Patients aged 16 years or younger

• Undergo adenoidectomy surgery

• Patients informed consent obtained from the parents

Inclusion Criteria for control group:

• Patients aged 16 years or younger

• Patients who did not need adenoidectomy surgery and any head and neck procedures

• Patients who underwent endotracheal intubation under general anesthesia except adenoidectomy and head and neck surgery.

Exclusion Criteria:

• Patients aged older than 16 years

• Patients with a history of syndromal craniofacial abnormalities

• Patients with systemic disorders and other otolaryngologic problems

Related Conditions & MeSH terms

• Adenoid Disease - Chronic
• Adenoidal Hypertrophy
• Children, Only
• Complication
• Hypertrophy
• Side Effect

Intervention

Diagnostic Test:
• Ultrasonography imaging
This study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas.

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya	Selcuklu

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from preoperative measurement to postoperative measurement in tongue surface area on the ultrasonography imaging.	This study aimed to evaluate the change from baseline in tongue surface area on the ultrasonography imaging due to the tongue depressor.	2018-2019 (6 months)
Secondary	Detection of swelling formation in tongue by using ultrasonography imaging.	This study aimed to measure and detect the tongue swelling by using ultrasonography imaging due to the tongue depressor.	2018-2019 (6 months)